NCT01912976

Brief Summary

Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is an effective treatment for Bowen's disease (BD) of the lower extremities. Er:YAG ablative fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in treating BD of the lower extremities in Asians.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

July 9, 2013

Last Update Submit

July 30, 2013

Conditions

Bowen's Disease

Keywords

Bowen's diseaseEr:YAGAFL-assistedMAL-PDT

Outcome Measures

Primary Outcomes (1)

  • Difference the efficacy between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL-PDT) and standard MAL-PDT.

    Lesion response was classified as either complete (complete disappearance of the lesion) or incomplete (incomplete disappearance) on the basis of visual examination and palpation. The response of each lesion was clinically evaluated

    Efficacy was evaluated at 3 months and 12 months after treatment

Secondary Outcomes (1)

  • Difference of the cosmetic outcomes between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL-PDT) and standard MAL-PDT.

    Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 3 or 12 months

Other Outcomes (1)

  • Difference of the recurrence rates and safety between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL-PDT) and standard MAL-PDT.

    within 12 months after both treatment

Study Arms (2)

Er:YAG AFL-PDT

EXPERIMENTAL

Right leg on each patients was assigned a single session of Er:YAG AFL-PDT.

Drug: Er:YAG AFL-PDT

MAL-PDT

ACTIVE COMPARATOR

Left leg on each patient was selected to receive 2 sessions of MAL-PDT

Drug: MAL-PDT

Interventions

Er:YAG AFL-PDTDRUG

Er:YAG AFL was performed with 550-600 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. MAL cream was then applied under occlusion for 3 hrs and illuminated with a red light-emitting diode light at 37 J/cm2.

Also known as: Er:YAG ablative fractional laser-assisted MAL-PDT
Er:YAG AFL-PDT
MAL-PDTDRUG

a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. Each treatment area was then separately illuminated with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm-2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later.

Also known as: methyl aminolaevulinate-Photodynamic therapy
MAL-PDT

Eligibility Criteria

Age18 Years - 92 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Korean patients aged ≥ 18 years who had biopsy-confirmed BD lesions on the lower extremities

You may not qualify if:

  • porphyria,
  • known allergies to the MAL cream or lidocaine,
  • pregnancy,
  • lactation,
  • any active systemic infectious disease,
  • immunosuppressive treatment,
  • personal history of malignant melanoma,
  • tendency towards melasma or keloid formation,
  • prior treatment of the lesions within 4 weeks, and
  • any indication of poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dong-A University

Busan, Dong Dae Sin-dong, Seo-gu, 602-715, South Korea

Location

MeSH Terms

Conditions

Bowen's Disease

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Study Officials

  • Ki-Hoon Song, M.D., Ph.D.

    Assistant professor and Chariman, Department of dermatology Dong-A University, College of medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 31, 2013

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 1, 2013

Record last verified: 2013-07

Locations

KR(1)